- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03960749
Headache After Diagnostic Lumbar Puncture (HELPUmeå)
May 20, 2019 updated by: Jonatan Salzer
The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial
The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study:
- Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
- Sprotte 22 G (0.7 mm) atraumatic needle with introducer
- Spinocan 25 G (0.5 mm) cutting needle
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
- Willing to participate and
- Providing informed consent
Exclusion Criteria:
-Subjects unable to participate in the study follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sprotte 25G needle, stylet reinserted
|
Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
|
Experimental: Sprotte 25G needle, stylet not reinserted
|
Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
|
Experimental: Sprotte 22G needle, stylet reinserted
|
Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
|
Experimental: Sprotte 22G needle, stylet not reinserted
|
Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
|
Experimental: Spinocan 25G needle, stylet reinserted
|
Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
|
Experimental: Spinocan 25G needle, stylet not reinserted
|
Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Odds ratio for post-lumbar puncture headache (any)
Time Frame: Up to 14 days after LP
|
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
|
Up to 14 days after LP
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Odds ratio for post-lumbar puncture headache (severe)
Time Frame: Up to 14 days after LP
|
Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
|
Up to 14 days after LP
|
Headache duration (days)
Time Frame: Until cessation, up to 14 days after LP
|
Until cessation, up to 14 days after LP
|
|
Proportion using analgesia
Time Frame: During post-lumbar puncture headache, up to 14 days after LP
|
During post-lumbar puncture headache, up to 14 days after LP
|
|
Proportion on sick leave
Time Frame: During post-lumbar puncture headache, up to 14 days after LP
|
During post-lumbar puncture headache, up to 14 days after LP
|
|
Proportion with back pain
Time Frame: Up to 14 days after LP
|
Up to 14 days after LP
|
|
Proportion with radiating leg pain
Time Frame: Up to 14 days after LP
|
Up to 14 days after LP
|
|
Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
Time Frame: Up to 14 days after LP
|
Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables.
Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.
|
Up to 14 days after LP
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure duration (minutes)
Time Frame: During the lumbar puncture
|
Procedure duration from start of procedure (defined as when the operator starts palpating the iliac crest) until procedure cessation (defined as when the needle is withdrawn from the participant).
|
During the lumbar puncture
|
Proportion undergoing needle switch
Time Frame: During the lumbar puncture
|
Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ.
|
During the lumbar puncture
|
Opening pressure (cm H2O)
Time Frame: During the lumbar puncture
|
Opening pressure measured immediately after cerebrospinal fluid (CSF) contact using a thin tube attached to a paper ruler, using the skin entry hole as reference point.
This is only performed in the recumbent position.
|
During the lumbar puncture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology. 2000 Oct 10;55(7):909-14. doi: 10.1212/wnl.55.7.909. No abstract available.
- Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.
- Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
- Strupp M, Brandt T. Should one reinsert the stylet during lumbar puncture? N Engl J Med. 1997 Apr 17;336(16):1190. doi: 10.1056/NEJM199704173361616. No abstract available.
- Hammond ER, Wang Z, Bhulani N, McArthur JC, Levy M. Needle type and the risk of post-lumbar puncture headache in the outpatient neurology clinic. J Neurol Sci. 2011 Jul 15;306(1-2):24-8. doi: 10.1016/j.jns.2011.04.004. Epub 2011 May 5.
- Strupp M, Schueler O, Straube A, Von Stuckrad-Barre S, Brandt T. "Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches. Neurology. 2001 Dec 26;57(12):2310-2. doi: 10.1212/wnl.57.12.2310.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2013
Primary Completion (Actual)
June 24, 2018
Study Completion (Actual)
October 11, 2018
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
May 20, 2019
First Posted (Actual)
May 23, 2019
Study Record Updates
Last Update Posted (Actual)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 20, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HELP Umeå
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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